App-Delivered Sleep Coaching for Cancer

(ACCESS Trial)

Overseen By Marjorie A Nelson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Must not be taking: Prescription sleep medications

Disqualifiers: Pregnancy, Psychiatric conditions, Shift work, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have changed the type or dose of any prescription sleep medications in the past three months.

What data supports the effectiveness of the treatment Sleep coaching, Sleep education for cancer patients?

A study on a behavioral therapy intervention for breast cancer patients showed that a sleep-focused program improved sleep quality and reduced cancer-related fatigue over a year. This suggests that sleep coaching and education could be beneficial for cancer patients. ^{1 2 3 4 5}

Is app-delivered sleep coaching safe for cancer patients?

The research does not provide specific safety data for app-delivered sleep coaching, but it highlights that sleep disturbances are common in cancer patients and need more attention. No adverse safety concerns are mentioned in the context of sleep interventions for cancer patients. ^{6 7 8 9 10}

How does app-delivered sleep coaching for cancer differ from other treatments for sleep issues in cancer patients?

App-delivered sleep coaching is unique because it provides personalized sleep guidance through a mobile app, making it more accessible and convenient compared to traditional in-person sleep interventions. This approach can be tailored to individual needs and schedules, potentially improving adherence and effectiveness in managing sleep disturbances commonly experienced by cancer patients. ^{1 7 10 11 12}

What is the purpose of this trial?

The proposed study will test the feasibility and acceptability of enrolling and retaining cancer survivors and their bedroom partners in a study evaluating digitally delivered behavioral sleep interventions.

Research Team

Rina S. Fox, PhD, MPH

Principal Investigator

University of Arizona College of Nursing

Eligibility Criteria

This trial is for cancer survivors and their partners who share a bedroom. It's designed to see if they can join and stay in a study that tests digital sleep help tools.

Inclusion Criteria

Score 8 to 14 on the Insomnia Severity Index (ISI)

I finished my cancer treatment between 6 months and 5 years ago, except for ongoing hormone therapy.

Have a consistent bedroom partner (i.e., sleep in the same bedroom 4 or more nights per week)

Exclusion Criteria

My sleep medication type and dose have been the same for the last 3 months.

Not planning to travel across 3 time zones or more during the eight intervention weeks or for the two weeks leading up to study assessments

Not pregnant at enrollment or planning to become pregnant during the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week sleep coaching program delivered by smartphone/tablet app or electronic access to educational information about sleep

8 weeks

Follow-up

Participants are monitored for satisfaction and changes in sleep health, insomnia symptoms, and symptom burden immediately after the intervention

4 weeks

Treatment Details

Interventions

• Sleep coaching
• Sleep education

Trial Overview The study is looking at how well an app that provides sleep coaching works compared to one that just gives information about sleep. The goal is to improve the quality of rest for both cancer survivors and their partners.

Participant Groups

Group I: Sleep coaching Experimental Treatment 1 Intervention

Participants will receive an 8-week sleep coaching program delivered by smartphone/tablet app

Group II: Sleep education Active Control 1 Intervention

Participants will receive electronic access to educational information about sleep for 8 weeks

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Findings from Research

Cancer-related fatigue may be linked to disrupted sleep and irregular sleep/wake cycles, suggesting that improving sleep quality could help alleviate daytime fatigue in cancer patients.

Inadequate or unrefreshing sleep not only contributes to fatigue but also affects the overall quality of life, treatment tolerance, and may lead to mood disorders in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between fatigue and sleep in cancer patients: a review. Ancoli-Israel, S., Moore, PJ., Jones, V.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Comparison of subjectively and objectively assessed sleep problems in breast cancer patients starting neoadjuvant chemotherapy. [2021]

2. Brazil pubmed.ncbi.nlm.nih.gov

Association between poor clinical prognosis and sleep duration among breast cancer patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

One-year outcomes of a behavioral therapy intervention trial on sleep quality and cancer-related fatigue. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Relationship between subjective and actigraphy-measured sleep in 237 patients with metastatic colorectal cancer. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Sleep quality in individuals diagnosed with colorectal cancer: Factors associated with sleep disturbance as patients transition off treatment. [2019]

6. Canada pubmed.ncbi.nlm.nih.gov

"I can't sleep!": gathering the evidence for an innovative intervention for insomnia in cancer patients. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Sleep-wake disturbances in people with cancer part II: evaluating the evidence for clinical decision making. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Actigraphy for measurements of sleep in relation to oncological treatment of patients with cancer: a systematic review. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Sleep-wake functioning along the cancer continuum: focus group results from the Patient-Reported Outcomes Measurement Information System (PROMIS(®)). [2021]

10. England pubmed.ncbi.nlm.nih.gov

The relationship between fatigue and sleep in cancer patients: a review. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Dyadic sleep intervention for adult patients with cancer and their sleep-partner caregivers: A feasibility study. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Feasibilty of a sleep intervention during adjuvant breast cancer chemotherapy. [2015]